Portal Inflow Modulation Prior to Liver Transplantation in Patients With Increased Risk of Intraoperative Blood Loss

NCT07111221 | Recruiting DMC

• 1 other identifier: ABM32
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

Brief Summary

Liver transplantation is a procedure associated with an exceptionally high risk of blood loss. Liver failure, which is the most common indication for transplantation, not only leads to coagulation disorders but also to the development of portal hypertension. As a result, collateral circulation forms within the abdominal venous system, significantly increasing the risk of massive intraoperative blood loss. The number of intraoperatively transfused units of red blood cell concentrate is one of the main predictors of serious complications and postoperative mortality. Patients with portal hypertension awaiting liver transplantation should be treated with non-selective β-blockers, which reduce pressure in the portal system. This is primarily justified by the need to prevent esophageal variceal bleeding, one of the most common causes of decompensation in chronic liver failure and a potential cause of death while awaiting liver transplantation. According to the Baveno VII guidelines, if bleeding recurs despite the use of non-selective β-blockers, a transjugular intrahepatic portosystemic shunt (TIPS) should be considered. Significant reduction of portal pressure is observed in up to 50% of patients treated with propranolol and up to 75% with carvedilol. TIPS effectively prevents bleeding caused by portal hypertension. However, recommendations for pre-transplant management of portal hypertension do not address the reduction of blood loss risk during liver transplantation. Previous studies evaluating the use of TIPS before transplantation primarily confirmed its safety and showed no significant increase in intraoperative risk. One analysis even suggested using TIPS in all patients with portal hypertension awaiting liver transplantation. Although some studies have addressed the issue of blood loss during transplantation, they were observational and retrospective, without distinguishing patients at particularly high risk of massive blood loss. So far, the effectiveness of TIPS in reducing blood loss during liver transplantation has not been confirmed-nor have studies reliably excluded such potential. The objective of the study is to directly compare the effectiveness of two different methods of modulating portal hypertension in the context of the risk of massive blood loss during liver transplantation. We hypothesize that the superior effectiveness of TIPS in significantly reducing portal hypertension may lead to a significant decrease in blood loss and the need for transfusion of blood products in patients at high risk of massive blood loss.

Conditions

Liver Cirrhosis; Clinically Significant Portal Hypertension

Outcome Measures

Primary Outcomes (1)

• Number of red blood cell units transfused during liver transplantation.

  Intraoperative

Secondary Outcomes (7)

• Portal vein blood flow

  Intraoperative

• Intraoperative blood loss

  Intraoperative

• Operation time

  Intraoperative

• Postoperative complications

  Up to 90 days

• Time of hospitalisation

  Up to 90 days

Study Arms (2)

Non-selective beta blockers

ACTIVE COMPARATOR

Non-selective beta blockers for treatment of portal hypertension

Drug: Non-selective beta-blockers

Non-selective beta blockers + TIPS

EXPERIMENTAL

Non-selective beta blockers and TIPS for treatment of portal hypertension

Procedure: Transjugular Intrahepatic Portosystemic Shunt; Drug: Non-selective beta-blockers

Interventions

Transjugular Intrahepatic Portosystemic Shunt PROCEDURE

Transjugular Intrahepatic Portosystemic Shunt performed prior to liver transplantation in patients with increased risk of intraoperative blood loss

Also known as: TIPS

Non-selective beta blockers + TIPS

Non-selective beta-blockers DRUG

Non-selective beta-blockers for lowering portal hypertension

Also known as: NSBBs

Non-selective beta blockers; Non-selective beta blockers + TIPS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Qualification for elective liver transplantation from a deceased donor
• Age ≥18 years
• BMI between 18.5 kg/m² and 30 kg/m²
• Informed consent to participate in the study
• Clinically significant portal hypertension
• At least 1 of the following risk factors for massive blood loss:
• Re-transplantation
• Previous surgery in the upper abdomen
• History of esophageal variceal bleeding
• History of spontaneous bacterial peritonitis
• Planned thrombectomy during liver transplantation

You may not qualify if:

• Heart failure (EF \<50%)
• Severe right ventricular failure
• Severe pulmonary hypertension
• Systemic infection
• Portal vein thrombosis (Yerdel \>1)
• Severe coagulopathy (INR \>5)
• Thrombocytopenia \<20,000/ml
• Severe or uncontrolled encephalopathy (ammonia concentration \>100 μmol/l)
• Contraindication to TIPS
• Contraindication to therapy with non-selective beta-blockers
• Pregnancy
• Lack of informed consent to participate in the study

Sponsors & Collaborators

• Medical University of Warsaw: lead
• Medical Research Agency, Poland: collaborator

Study Sites (1)

University Clinical Centre of the Medical University of Warsaw

Warsaw, Poland

RECRUITING

MeSH Terms

Conditions

Liver Cirrhosis

Interventions

Portasystemic Shunt, Transjugular Intrahepatic

Condition Hierarchy (Ancestors)

Liver Diseases; Digestive System Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Portasystemic Shunt, Surgical; Anastomosis, Surgical; Surgical Procedures, Operative; Vascular Grafting; Vascular Surgical Procedures; Cardiovascular Surgical Procedures

Central Study Contacts

Wacław Hołówko, dr hab. n. med.

CONTACT

+48 667 667 044; waclaw.holowko@wum.edu.pl

Zuzanna Łuczak

CONTACT

luczakpresite@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2025
• First Posted: August 8, 2025
• Study Start: June 24, 2025
• Primary Completion (Estimated): October 1, 2029
• Study Completion (Estimated): December 1, 2029
• Last Updated: August 8, 2025

Record last verified: 2025-06

Locations

PL (1)